Doull 1995.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Allen and Hanbury (UK) and the Wessex Medical Trust |
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Participants | Setting: 5 health centres in the Southampton area Eligible: 104 Randomly assigned: 52 (beclomethasone 200 μg); 52 (placebo) Analysed: 44 (beclomethasone 200 μg); 40 (placebo) Gender (male): 70.1% Age, months, mean ± SE: beclomethasone 100.3 ± 1.4; placebo 99.4 ± 1.6 Inclusion criteria: children 7 to 9 years of age, with 5 or more wheezing episodes in the preceding year or an episode of wheezing lasting for 3 days or longer in the preceding year Exclusion criteria: use of inhaled or oral corticosteroids; severe respiratory disease such as cystic fibrosis Previous regular use of ICS: not allowed |
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Interventions | Test group:
Control group: matching placebo Treatment was delivered twice daily via Diskhaler. Treatment duration was 7 months, followed by a washout period of 4 months |
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Outcomes |
Height was measured by a single observer in triplicate at each visit, using a Raven monitor |
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Notes | Treatment compliance was measured by counting the used Diskhaler blisters. Compliance rate was 75.2% in the beclomethasone group and 75.9% in the placebo group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Use of matching placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Use of matching placebo |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawal rate was 2/52 (3.8%) in the beclomethasone group and 8/52 (15.4%) in the placebo group |
Selective reporting (reporting bias) | Low risk | Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | Study appears to be free of other sources of bias |